The SELEQT-HF (SELEnium and CoQ10 NuTrition for Heart Failure) Study Will Evaluate the Effect of Adding Selenium/and coQ10 on Top of Standard HF Therapy in Patients With HF and Will do so Using a Pragmatic, Registry Based Randomized Controlled Trial in the Netherlands. (SELEQT-HF)

A Registry-Based Randomised Controlled Trial With Heart 4 Data - SELEnium and CoQ10 NuTrition for Heart Failure: H4D-SELEQT-HF

The goal of this clinical trial is to learn whether taking selenium and coenzyme Q10 (CoQ10) can reduce HF related events and deaths related to cardiovascular disease.

Researchers will compare selenium-CoQ10 supplements with a placebo to see if the supplements improve heart health and patient outcomes.

Participants will:

Receive either selenium-CoQ10 or placebo in addition to their usual heart failure treatment

Attend standard clinical visits according to routine clinical care.

The study will include 1,100 adults with chronic heart failure. Selenium and CoQ10 are natural nutrients with no known health risks. If effective, this supplement could provide a safe new way to improve outcomes for people with heart failure.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Dietary supplement: Selenium/CoQ10; Drug: Matching Placebo (B)

Detailed Description

This randomized controlled trial will be a pragmatic registry based clinical trial (RBRCT), using existing infrastructure on quality reporting of cardiovascular disease management in the Netherlands. This registration platform (Netherlands Heart Registration (NHR) forms the basis of incorporating information of patients with HF in hospitals in the Netherlands. Using the data gathered through this registry, these data will serve as source documentation for the electronic case report form of the current RBRCT and requires only limited additional information. Through the same system, randomization, (Serious) adverse event reporting, endpoint reporting and investigational product allocation will be conducted. Investigational product (selenium/CoQ10 supplementation or placebo) will be distributed from central pharmacy to the home of the patient. Apart from telephone calls at 6 months after randomization and every 12 months thereafter, there will be no study visits and the data gathering will be conducted through routine clinical care and registrations that are already in place. SELEQT-HF is an event driven RBRCT, with an expected median follow up of 2 years.

• Study Type: Interventional
• Enrollment (Estimated): 1100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: SELEQT-HF Study Team; Phone Number: +31 (0)503616161; Email: seleqt-hf@umcg.nl

Study Locations

• Netherlands
  • Alkmaar, Netherlands
    • Not yet recruiting
    • Noordwest Ziekenhuisgroep
    • Contact: Jan van Ramshorst, MD, PhD; Phone Number: 0031725484444; Email: seleqt-hf@umcg.nl
  • Amsterdam, Netherlands
    • Not yet recruiting
    • AUMC
    • Contact: Marielle C van de Veerdonk, MD, PhD; Phone Number: 0031205669111; Email: seleqt-hf@umcg.nl
  • Breda, Netherlands
    • Recruiting
    • Amphia Ziekenhuis
    • Contact: Jeroen Schaap, MD, PhD; Phone Number: 0031765955000; Email: seleqt-hf@umcg.nl
  • Eindhoven, Netherlands
    • Not yet recruiting
    • Catharina Ziekenhuis Eindhoven
    • Contact: René Tio, MD, PhD; Phone Number: 0031402399111; Email: seleqt-hf@umcg.nl
  • Emmen, Netherlands
    • Not yet recruiting
    • Treant
    • Contact: Solmaz Assa, MD, PhD; Phone Number: 0031881292929; Email: seleqt-hf@umcg.nl
  • Groningen, Netherlands, 9713GZ
    • Recruiting
    • University Medical Center Groningen
    • Contact: Kevin Damman, MD, PhD; Phone Number: 0031503616161; Email: seleqt-hf@umcg.nl
    • Contact: Peter van der Meer, Prof Dr; Phone Number: 0031503616161; Email: seleqt-hf@umcg.nl
    • Sub-Investigator: Mats Kutscher, MD
  • Nieuwegein, Netherlands
    • Not yet recruiting
    • St Antonius Ziekenhuis
    • Contact: Geert PJ van Hout, MD, PhD; Phone Number: 0031883203000; Email: seleqt-hf@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >18 years
• Outpatients with chronic HF, NYHA II - ambulatory IV
• Serum NT-proBNP concentrations >600 pg/mL (71 pmol/L) if in sinus rhythm; >1000pg/mL (118 pmol/L) if in Atrial fibrillation*

Exclusion Criteria:

• History of myocardial infarction, myocarditis, percutaneous intervention, cardiac surgery or stroke <30 days
• The presence of a mechanical assist device
• Scheduled for mechanical assist device or heart transplant
• Other non-cardiac conditions with limited life expectancy (<1 year)
• Amyloid, hypertrophic obstructive or constrictive cardiomyopathy
• End stage kidney disease for which chronic intermittent peritoneal or haemodialysis
• Unable to sign informed consent
• (Unwilling to stop) use of over the counter supplements coQ10/selenium
• Peanut and/or soy allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Matching Placebo (B); Matching Placebo
Experimental: Selenium/CoQ10; Oral dosage of twice daily Selenium/CoQ10 (2 x 100 μg selenium tablets (SelenoPrecise 100 μg, Pharma Nord, Denmark) and 2 x 100 mg Q10 capsules (Bio-Quinon 100 mg B.I.D, Pharma Nord, Denmark)	Dietary supplement: Selenium/CoQ10; Oral dosage of twice daily Selenium/CoQ10 (2 x 100 μg selenium tablets (SelenoPrecise 100 μg, Pharma Nord, Denmark) and 2 x 100 mg Q10 capsules (Bio-Quinon 100 mg B.I.D, Pharma Nord, Denmark)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of repeated HF hospitalization, repeated urgent HF visits and cardiovascular death	Total (first and subsequent) HF hospitalizations, urgent visits for HF visits and cardiovascular deaths with selenium/coQ10 compared to placebo.	ongoing, up to ~30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of events of (repeated) HF hospitalization and (repeated) urgent HF visits	Total number of (repeated) HF hospitalization and (repeated) urgent HF visits	ongoing, up to ~30 months
Time to death from any cause	time to death from any cause with selenium/coQ10 compared to placebo	ongoing, up to ~30 months
Time to cardiovascular death	Time to cardiovascular death with selenium/coQ10 compared to placebo	ongoing, up to ~30 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of (repeated) all cause hospitalizations	Total number of (repeated) all cause hospitalizations with selenium/coQ10 compared to placebo	ongoing, up to ~30 months
Total number of (repeated) unscheduled cardiovascular hospital visits	Total number of (repeated) unscheduled cardiovascular hospital visits with selenium/coQ10 compared to placebo	ongoing, up to ~30 months
Total days alive out of hospital	Total days alive out of hospital with selenium/coQ10 compared to placebo	ongoing, up to ~30 months
Side effects associated with study supplement	Side effects associated with study supplement	ongoing, up to 30 months

Collaborators and Investigators

• Sponsor: Netherlands Heart Institute
• Collaborators: University Medical Center Groningen; ZonMw: The Netherlands Organisation for Health Research and Development; Pharma Nord; WCN (Werkgroep Cardiologische centra Nederland); Hartstichting
• Investigators: Principal Investigator: Peter van der Meer, prof dr, University Medical Center Groningen; Principal Investigator: Jeroen Schaap, MD,PhD, Amphia Hospital Breda

Publications and helpful links

General Publications

• Alehagen U, Johansson P, Bjornstedt M, Rosen A, Dahlstrom U. Cardiovascular mortality and N-terminal-proBNP reduced after combined selenium and coenzyme Q10 supplementation: a 5-year prospective randomized double-blind placebo-controlled trial among elderly Swedish citizens. Int J Cardiol. 2013 Sep 1;167(5):1860-6. doi: 10.1016/j.ijcard.2012.04.156. Epub 2012 May 23.
• Mortensen SA, Rosenfeldt F, Kumar A, Dolliner P, Filipiak KJ, Pella D, Alehagen U, Steurer G, Littarru GP; Q-SYMBIO Study Investigators. The effect of coenzyme Q10 on morbidity and mortality in chronic heart failure: results from Q-SYMBIO: a randomized double-blind trial. JACC Heart Fail. 2014 Dec;2(6):641-9. doi: 10.1016/j.jchf.2014.06.008. Epub 2014 Oct 1.
• Bomer N, Grote Beverborg N, Hoes MF, Streng KW, Vermeer M, Dokter MM, IJmker J, Anker SD, Cleland JGF, Hillege HL, Lang CC, Ng LL, Samani NJ, Tromp J, van Veldhuisen DJ, Touw DJ, Voors AA, van der Meer P. Selenium and outcome in heart failure. Eur J Heart Fail. 2020 Aug;22(8):1415-1423. doi: 10.1002/ejhf.1644. Epub 2019 Dec 6.
• Folkers K, Vadhanavikit S, Mortensen SA. Biochemical rationale and myocardial tissue data on the effective therapy of cardiomyopathy with coenzyme Q10. Proc Natl Acad Sci U S A. 1985 Feb;82(3):901-4. doi: 10.1073/pnas.82.3.901.
• McKeag NA, McKinley MC, Harbinson MT, McGinty A, Neville CE, Woodside JV, McKeown PP. Dietary Micronutrient Intake and Micronutrient Status in Patients With Chronic Stable Heart Failure: An Observational Study. J Cardiovasc Nurs. 2017 Mar/Apr;32(2):148-155. doi: 10.1097/JCN.0000000000000322.

Helpful Links

• ZonMW project page SELEQT-HF

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: heart failure; selenium; coQ10; registry based randomized clinical trial
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Inorganic Chemicals; Elements; Chalcogens; Minerals; Selenium; coenzyme Q10
• Other Study ID Numbers: NL87982.042.24; METc 2025/02 (Other Identifier: METc UMC Groningen)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No